Bracing and Strengthening for Posterior Tibial Tendon Dysfunction
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Purpose
Posterior tibial tendon dysfunction (PTTD) is a problem with the tendon connecting one of the lower leg muscles to the foot bone. PTTD can cause pain, swelling, and a flattened foot and may require surgery if left untreated. Normal treatment for PTTD includes physical therapy exercise. In treating similar conditions in the lower leg, exercises that are active, like strengthening, seem to have better results than exercises that are passive, like stretching. This study will determine whether adding strengthening exercises to a normal PTTD treatment that includes wearing a brace and stretching is more beneficial than just wearing a brace and stretching.
| Condition | Intervention | Phase |
|---|---|---|
|
Posterior Tibial Tendon Dysfunction |
Device: Bracing Other: Strengthening exercises Other: Stretching exercises |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | The Effect of Bracing and Strengthening Exercises on Posterior Tibial Tendon Dysfunction |
- Foot function index [ Time Frame: Measured at Weeks 1, 6, and 12 ] [ Designated as safety issue: No ]
- Foot kinematics and posterior tibial muscle length (estimated from foot kinematics) [ Time Frame: Measured at baseline and Weeks 6 and 12 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
Participants in Group A will undergo bracing and perform stretching exercises.
|
Device: Bracing
Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.
Other Name: Air Lift Brace
Other: Stretching exercises
Participants will perform stretching exercises.
|
|
Experimental: B
Participants in Group B will undergo bracing and perform stretching and strengthening exercises.
|
Device: Bracing
Participants will wear a brace that includes ankle stirrup support and medial longitudinal arch support. The brace will be worn during weight-bearing tasks throughout the 12-week study.
Other Name: Air Lift Brace
Other: Strengthening exercises
Participants will perform strengthening exercises progressively longer each time for up to 3 sets of 30 repetitions twice daily by the third visit. Exercises will include bilateral heel raises, foot adduction/rear foot inversion with thera-tubing, and unilateral heel raises. Strengthening exercises will be preceded by a warm-up of the posterior tibialis muscle.
Other: Stretching exercises
Participants will perform stretching exercises.
|
Detailed Description:
Posterior tibial tendon dysfunction (PTTD) involves inflammation, overstretching, or both of the posterial tibial tendon, which connects the tibialis posterior muscle to the bones in the foot. PTTD can cause pain in the inner ankle and development of a flat foot. Without treatment, correction of PTTD may require surgery. Standard interventions that may prevent the need for surgery include orthotic devices, bracing, and physical therapy, among other possibilities. Within physical therapy, foot exercises can be either active—as in the case of strengthening exercises—or passive—as in the case of stretching exercises. Evidence from clinical treatment of similar conditions suggests that active exercises are more effective than passive exercises in leading to recovery. This study will determine whether adding strengthening exercises to a normal intervention of bracing and stretching is more effective in improving a range of symptoms in stage II PTTD patients than using only bracing and stretching exercises.
Participants with Stage II PTTD will be recruited and placed in one of two groups for the duration of the 12-week study. The first group will undergo regular bracing and perform stretching exercises. The second group will undergo regular bracing and perform stretching and strengthening exercises. Braces, worn during weight-bearing tasks throughout the study, will include ankle stirrup support and medial longitudinal arch support. Strengthening exercises, which will be preceded by a warm-up of the posterior tibialis muscle, will include bilateral heel raises, foot adduction and rear foot inversion with thera-tubing, and unilateral heel raises. Frequency of exercise and number of repetitions will increase over the course of the study until participants are performing 3 sets of 30 repetitions 2 times per day. Assessments, which will occur at study entry, after 6 weeks, and after 12 weeks, will include foot range of motion, length of the posterior tibial muscle, and self-assessments of function.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Stage II PTTD disorder
- Flexible flat foot deformity
- Palpable tenderness of posterior tibial tendon
- Swelling of the posterior tibial tendon sheath
- Pain during single limb heel rise
- Abnormal rear foot valgus
- Abnormal fore foot abduction as compared to contralateral side
Exclusion Criteria:
- Unable to walk for more than 15 meters
- Comorbidity within the foot
- Loss of protective sensation of the foot, as indicated by Semmes-Weinstein monofilament test of 5.07
- Inflammatory arthropathies
- Score greater than 23 on Mini Mental Status exam
- Arch index of less than 0.255
- Inability to assume a subtalar neutral posture
- PTTD in both feet
Contacts and Locations| United States, New York | |
| Ithaca College - Rochester Center | |
| Rochester, New York, United States, 14620 | |
| Principal Investigator: | Jeff R. Houck, PhD, PT | Ithaca College - Rochester Center |
More Information
No publications provided
| Responsible Party: | Dr. Jeff R. Houck, Associate Professor, Ithaca College-Rochester Center |
| ClinicalTrials.gov Identifier: | NCT00756457 History of Changes |
| Other Study ID Numbers: | R15 AR054507 |
| Study First Received: | September 19, 2008 |
| Last Updated: | May 5, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
|
PTTD Tendinopathy Tendon Injuries Muscular Diseases Foot Diseases |
Additional relevant MeSH terms:
|
Posterior Tibial Tendon Dysfunction Foot Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013